U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210132
Company: THERAPEUTICSMD INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BIJUVA ESTRADIOL; PROGESTERONE 1MG;100MG CAPSULE;ORAL Prescription AB Yes Yes
BIJUVA ESTRADIOL; PROGESTERONE 0.5MG;100MG CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/2018 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210132Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2021 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s006ltr.pdf
06/22/2021 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf
06/22/2021 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/2021 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf
06/22/2021 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf
06/22/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf
10/28/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf

BIJUVA

CAPSULE;ORAL; 1MG;100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BIJUVA ESTRADIOL; PROGESTERONE 1MG;100MG CAPSULE;ORAL Prescription Yes AB 210132 THERAPEUTICSMD INC
Back to Top